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      Sentinel Node Identification Rate and Nodal Involvement in the EORTC 10981-22023 AMAROS Trial

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          Abstract

          Background

          The randomized EORTC 10981-22023 AMAROS trial investigates whether breast cancer patients with a tumor-positive sentinel node biopsy (SNB) are best treated with an axillary lymph node dissection (ALND) or axillary radiotherapy (ART). The aim of the current substudy was to evaluate the identification rate and the nodal involvement.

          Methods

          The first 2,000 patients participating in the AMAROS trial were evaluated. Associations between the identification rate and technical, patient-, and tumor-related factors were evaluated. The outcome of the SNB procedure and potential further nodal involvement was assessed.

          Results

          In 65 patients, the sentinel node could not be identified. As a result, the sentinel node identification rate was 97% (1,888 of 1,953). Variables affecting the success rate were age, pathological tumor size, histology, year of accrual, and method of detection. The SNB results of 65% of the patients ( n = 1,220) were negative and the patients underwent no further axillary treatment. The SNB results were positive in 34% of the patients ( n = 647), including macrometastases ( n = 409, 63%), micrometastases ( n = 161, 25%), and isolated tumor cells ( n = 77, 12%). Further nodal involvement in patients with macrometastases, micrometastases, and isolated tumor cells undergoing an ALND was 41, 18, and 18%, respectively.

          Conclusions

          With a 97% detection rate in this prospective international multicenter study, the SNB procedure is highly effective, especially when the combined method is used. Further nodal involvement in patients with micrometastases and isolated tumor cells in the sentinel node was similar—both were 18%.

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          Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial.

          Robert Mansel, Lesley Fallowfield, Mark Kissin … (2006)
          Sentinel lymph node biopsy in women with operable breast cancer is routinely used in some countries for staging the axilla despite limited data from randomized trials on morbidity and mortality outcomes. We conducted a multicenter randomized trial to compare quality-of-life outcomes between patients with clinically node-negative invasive breast cancer who received sentinel lymph node biopsy and patients who received standard axillary treatment. The primary outcome measures were arm and shoulder morbidity and quality of life. From November 1999 to October 2003, 1031 patients were randomly assigned to undergo sentinel lymph node biopsy (n = 515) or standard axillary surgery (n = 516). Patients with sentinel lymph node metastases proceeded to delayed axillary clearance or received axillary radiotherapy (depending on the protocol at the treating institution). Intention-to-treat analyses of data at 1, 3, 6, and 12 months after surgery are presented. All statistical tests were two-sided. The relative risks of any lymphedema and sensory loss for the sentinel lymph node biopsy group compared with the standard axillary treatment group at 12 months were 0.37 (95% confidence interval [CI] = 0.23 to 0.60; absolute rates: 5% versus 13%) and 0.37 (95% CI = 0.27 to 0.50; absolute rates: 11% versus 31%), respectively. Drain usage, length of hospital stay, and time to resumption of normal day-to-day activities after surgery were statistically significantly lower in the sentinel lymph node biopsy group (all P .05). Sentinel lymph node biopsy is associated with reduced arm morbidity and better quality of life than standard axillary treatment and should be the treatment of choice for patients who have early-stage breast cancer with clinically negative nodes.
          Article 0 comments Cited 298 times – based on 0 reviews     Review now
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            A nomogram for predicting the likelihood of additional nodal metastases in breast cancer patients with a positive sentinel node biopsy.

            Michael W. Kattan, Jose Bevilacqua, Jack van Loon … (2003)
            The standard of care for breast cancer patients with sentinel lymph node (SLN) metastases includes complete axillary lymph node dissection (ALND). However, many question the need for complete ALND in every patient with detectable SLN metastases, particularly those perceived to have a low risk of non-SLN metastases. Accurate estimates of the likelihood of additional disease in the axilla could assist greatly in decision-making regarding further treatment. Pathological features of the primary tumor and SLN metastases of 702 patients who underwent complete ALND were assessed with multivariable logistic regression to predict the presence of additional disease in the non-SLNs of these patients. A nomogram was created using pathological size, tumor type and nuclear grade, lymphovascular invasion, multifocality, and estrogen-receptor status of the primary tumor; method of detection of SLN metastases; number of positive SLNs; and number of negative SLNs. The model was subsequently applied prospectively to 373 patients. The nomogram for the retrospective population was accurate and discriminating, with an area under the receiver operating characteristic (ROC) curve of 0.76. When applied to the prospective group, the model accurately predicted likelihood of non-SLN disease (ROC, 0.77). We have developed a user-friendly nomogram that uses information commonly available to the surgeon to easily and accurately calculate the likelihood of having additional, non-SLN metastases for an individual patient.
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              Comparison of models to predict nonsentinel lymph node status in breast cancer patients with metastatic sentinel lymph nodes: a prospective multicenter study.

              N Seince, Frédéric Marchal, Jean Leveque … (2009)
              Several models have been developed to predict nonsentinel lymph node (non-SN) status in patients with breast cancer with sentinel lymph node (SN) metastasis. The purpose of our investigation was to compare available models in a prospective, multicenter study. In a cohort of 561 positive-SN patients who underwent axillary lymph node dissection, we evaluated the areas under the receiver operating characteristic curves (AUCs), calibration, rates of false negatives (FN), and number of patients in the group at low risk for non-SN calculated from nine models. We also evaluated these parameters in the subgroup of patients with micrometastasis or isolated tumor cells (ITC) in the SN. At least one non-SN was metastatic in 147 patients (26.2%). Only two of nine models had an AUC greater than 0.75. Three models were well calibrated. Two models yielded an FN rate less than 5%. Three models were able to assign more than a third of patients in the low-risk group. Overall, the Memorial Sloan-Kettering Cancer Center nomogram and Tenon score outperform other methods for all patients, including the subgroup of patients with only SN micrometastases or ITC. Our study suggests that all models do not perform equally, especially for the subgroup of patients with only micrometastasis or ITC in the SN. We point out available evaluation methods to assess their performance and provide guidance for clinical practice.
              Article 0 comments Cited 69 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                : m.straver@nki.nl
                : e.rutgers@nki.nl
                Journal
                Journal ID (nlm-ta): Ann Surg Oncol
                Title: Annals of Surgical Oncology
                Publisher: Springer-Verlag (New York )
                ISSN (Print): 1068-9265
                ISSN (Electronic): 1534-4681
                Publication date (Electronic): 19 March 2010
                Publication date PMC-release: 19 March 2010
                Publication date (Print): July 2010
                Volume: 17
                Issue: 7
                Pages: 1854-1861
                Affiliations
                [1 ]Department of Surgical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
                [2 ]Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
                [3 ]Department of Radiation Oncology, Academic Medical Centre, Amsterdam, The Netherlands
                [4 ]Department of Surgery, University Medical Centre, Leiden, The Netherlands
                [5 ]Department of Surgery, University of Wales College of Medicine, Cardiff, Wales UK
                [6 ]European Organisation of Research and Treatment of Cancer, Brussels, Belgium
                [7 ]Department of Surgery, Universita Degli studi di Firenze, Firenze, Italy
                [8 ]Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands
                [9 ]Department of Radiation Oncology, ARTI Institute for Radiation Oncology, Arnhem, The Netherlands
                [10 ]Department of Surgery, Nij Smellinghe Hospital, Drachten, The Netherlands
                [11 ]Department of Surgery, Institute of Oncology, Ljubljana, Slovenia
                [12 ]Department of Radiation Oncology, Catherina Hospital, Eindhoven, The Netherlands
                Article
                Publisher ID: 945
                DOI: 10.1245/s10434-010-0945-z
                PMC ID: 2889289
                PubMed ID: 20300966
                SO-VID: 0e8d223a-1eb4-4f71-b92f-651026f96650
                Copyright © © The Author(s) 2010
                History
                Date received : 19 June 2009
                Categories
                Subject: Breast Oncology
                Custom metadata
                issue-copyright-statement © Society of Surgical Oncology 2010

                ScienceOpen disciplines: Oncology & Radiotherapy
                Data availability:
                ScienceOpen disciplines: Oncology & Radiotherapy

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